Rethinking Novelty in Patent Law

The novelty requirement seeks to ensure that a patent will not issue if the public already possesses the invention. Although gauging possession is usually straightforward for simple inventions, it can be difficult for those in complex fields like biotechnology, chemistry, and pharmaceuticals. For example, if a drug company seeks to patent a promising molecule that was disclosed but never physically made in the prior art, the key possession question is whether a person having ordinary skill in the art (PHOSITA) could have made it at the time of the prior disclosure. Put differently, could the PHOSITA rely on then-existing knowledge in the field to fill in any missing technical details from the prior disclosure? This Article argues that existing novelty jurisprudence mishandles the possession question in two ways. First, it tends to overestimate the PHOSITA’s then-existing knowledge by failing to fully appreciate the complex nature of certain technologies. Second, the current examination framework vitiates the presumption of novelty by placing proof burdens on the would-be inventor that can thwart innovation and frustrate important objectives of the patent system. To resolve these problems and to fill a gap in patent scholarship, this Article proposes a new paradigm that reframes the novelty inquiry during patent examination. Its implementation will not only improve the quality of issued patents, but make the patent literature a more robust source of technical information. This Article contributes to broader policy debates over patent reform and joins a larger effort to bridge the disconnect between patent law and the norms of science.

[1]  R. Weinshilboum The therapeutic revolution , 1987, Clinical pharmacology and therapeutics.